BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 10236965 · Received July 6, 2020

    Report

    Report Number
    1221934-2020-01751
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 22, 2020
    Report Date
    June 22, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001279
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THIS WAS AN ARTHROSCOPIC BRISTOW PROCEDURE TREATING UNSTABLE ANTERIOR SHOULDER JOINT ON (B)(6) 2020. THE GRYPHON (210813) IN QUESTION WAS INSERTED AS THE 4TH IMPLANT INTO THE GLENOID CAVITY. THEN, IT APPEARED THAT THE EYELET BROKE AND THE SUTURE CAME OFF. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. SINCE THE COMPLAINT DEVICE NOT BEING RETURNED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [6L40857] NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS AN ARTHROSCOPIC BRISTOW PROCEDURE TREATING UNSTABLE ANTERIOR SHOULDER JOINT ON (B)(6) 2020. THE GRYPHON (210813) IN QUESTION WAS INSERTED AS THE 4TH IMPLANT INTO THE GLENOID CAVITY. THEN, IT APPEARED THAT THE EYELET BROKE AND THE SUTURE CAME OFF. THE SURGEON CONFIRMED THAT A PART OF THE FRAGMENTS REMAINED IN THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT WITHOUT SURGICAL DELAY. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE FRAGMENTS WERE NOT REMOVED FROM THE PATIENT AND THERE WERE NO COMPLICATIONS REPORTED. IT WAS ALSO REPORTED THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701458 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 210813 6L40857 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1